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New Non-Implanted device aims to ease overactive bladder woes

NCT ID NCT06885099

Symptom relief Sponsor: FemPulse Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether women with overactive bladder (OAB) could easily use the FemPulse System, a non-implanted vaginal electrical stimulation device. Eleven women with OAB symptoms used the device and completed a survey about its usability. The goal was simply to see if the system is user-friendly, not to measure how well it treats OAB.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FemPulse System (non-implanted vaginal electrical stimulation device)
What this could lead to
If successful, this device could offer a simple, drug-free option for women to manage overactive bladder symptoms at home.
What could go wrong
This was a very small, completed study (11 people) focused only on ease of use, not on how well the device treats symptoms. Results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11 people

The number who actually took part.

Started

Feb 2025

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Females, defined as a person with a cervix, ≥21 years old, with OAB symptoms, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms . 2. Able to read, comprehend, and reliably provide informed consent and study-related information. 3. Willing and able to comply with study required procedures and visits Exclusion Criteria: 1. Any significant pain, neurologic, psychological condition or other factors, that in the investigator's judgment, might confound the protocol study assessments, and adherence to the protocol. 2. Has a metal pelvic implant or an active implantable medical device, including but not limited to a cardiac pacemaker, cardioverter-defibrillator or neurostimulator 3 History of a cardiac condition including, but not limited to, clinically significant abnormal ECG or arrhythmia that may interfere with study participation as determined by investigator. 4\. Systemic condition or disease that may interfere with study participation or not an appropriate study candidate, as determined by study investigator.

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Conditions

The condition(s) this trial relates to.

overactive bladder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overactive bladder (OAB)

Contacts and locations

Locations

  • Holy Cross Women's Hospital

    Fort Lauderdale, Florida, 33334, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.